Steps For Proper Cleaning Validation

By Michael Moussourakis, Jeff Phillips, Stacy Silverstein, and Malcolm McLaughlin

This chapter of The Aqueous Cleaning Handbook looks at how cleaning validation is a critical component of the pharmaceutical industry, medical device industry, and other industries adhering to Current GMP and Quality Systems Regulations. The cleaning validation study involves testing manufacturing surfaces to ensure that they are being cleaned to an acceptable level of residue, documenting that testing data, and establishing procedures to maintain that level of cleanliness. Each industry and application has unique concerns, considerations, and goals regarding cleaning validation.

The validation study is performed on those critical cleaning steps that affect the quality or safety of the final product, which typically means focusing on surfaces that come into contact with the product. In some low-volume, high-value medical device manufacturing, it is more practical to verify cleaning on each individual device manufactured. However, in most pharmaceutical or large-volume medical device manufacturing, verification of acceptable levels of contamination is focused on certain specified steps, and a sample of manufactured products is tested for contamination.